CN1591010A - Method and system for determining acceptability of signal data collected from prothrombin time test strip - Google Patents
Method and system for determining acceptability of signal data collected from prothrombin time test strip Download PDFInfo
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- CN1591010A CN1591010A CNA031327613A CN03132761A CN1591010A CN 1591010 A CN1591010 A CN 1591010A CN A031327613 A CNA031327613 A CN A031327613A CN 03132761 A CN03132761 A CN 03132761A CN 1591010 A CN1591010 A CN 1591010A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
- G01N33/523—Single-layer analytical elements the element being adapted for a specific analyte
Abstract
A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip includes collecting PT signal data from an assay area and control areas of the PT test strip. Relationships between PT signal data collected from the assay area and PT signal data collected from each of the control areas (e.g., a ratio of post-peak pseudo-slopes) are then ascertained. A determination is subsequently made, based on the relationships, as to whether the PT signal data collected from the assay area is acceptable or not for use in calculating a PT and/or an International Normalization Ratio (INR). This determination can include, for example, comparing the relationships to at least one predetermined threshold limit. A prothrombin time (PT) monitoring system includes a PT test strip and a device. The PT test strip includes an assay area and a control area. The device (e.g., a portable hand-held meter) includes an optical measurement means (e.g., an LED/photo-detector pair) for measuring an optical property (e.g., absorption) of the assay area and control areas, an analog-to-digital converter module, a microprocessor module and a memory module.
Description
Technical field
Generally, the application relates to the method and system of the acceptability of determining signal data, is specifically related to be used for determining to gather from prothrombin time test-strips (prothrombin time test strips) method and system of the acceptability of next signal data.
Background technology
The monitoring system that generally is used to measure the fluid sample feature comprises device and the top test-strips (for example prothrombin time (PT) test-strips) that will apply fluid sample (for example whole blood sample) such as the portable hand-held meter.Described device and test-strips are used to measure the analyte concentration (for example blood sugar concentration) or the further feature (for example clotting time and/or international normalized ratio (INR)) of fluid sample altogether.Described device generally will be measured one or more characteristics (for example optics reflecting rate, light transmission, absorptivity or electrochemical properties) of test-strips, adopts one or more algorithm computation features according to one or more characteristics that record then.
For those of ordinary skills, various traditional prothrombin time (PT) monitoring system that is used to measure the blood coagulation time (being prothrombin time) of user's whole blood sample is known.For example, the PT monitoring system of this quasi-tradition has just been described in United States Patent (USP) 6261519 and United States Patent (USP) 6084660 and European patent application EP 0974840, preceding two pieces of document integral body are incorporated at this by reference.These traditional PT monitoring systems are generally used by the layman, and his door utilizes the prescription class anticoagulant of Warfarin class to monitor the solid situation of anti-freezing of their oral area.
Traditional PT monitoring system need use external control liquid to verify the prothrombin time of this system's generation and/or the test result of INR.This checking is for for fear of being necessary because of having used PT test-strips under the hostile environment condition that is exposed to (for example high temperature and/or high humidity) to produce for the wrong result for example.On this meaning, extremely not that PT test-strips under the environmental baseline that must be harmful to is called as " forcing (stressed) " PT test-strips although be exposed to.
Utilize the checking of external control liquid result of implementation to learn and carry out, wherein will suppose the characteristic of the result's energy analog subscriber fluid sample that obtains by external control liquid according to the laboratory method of quality control.But,, must be doubly cautious to contrasting the liquid and the coupling of reagent lot number and the correct control of storage and service condition in order to allow this supposition remain valid.Unfortunately, the unprofessional person does not understand or does not note batch mixing, storage is improper or service condition consequence improperly.This do not understand or ignore can allow result's that conventional P T monitoring system is produced checking make great efforts to become complicated.In addition, many users know external control liquid, and it requires a plurality of preparation process and complicated training, therefore are difficult to adopt.
Therefore, this field also needs a kind of accurate method and system to judge from the acceptability of the signal data of prothrombin time (PT) test-strips acquisition.This method and system should can decision signal data whether for example (for example high temperature and/or high humidity) becomes unacceptable under the hostile environment condition because of the PT test-strips is exposed to.This method and system also should be integrated in the portable hand-held meter with plain mode.
Summary of the invention
The invention provides the method and system of the acceptability of the prothrombin time signal data that judgement collects from prothrombin time (PT) test-strips.Because this judgement is based on the PT signal data that collects from the chemical examination zone of PT test-strips and the PT signal data that collects from least one control zone of PT test-strips between a kind of definite relation, so these method and systems are more accurate.Therefore it is comparative quantity in nature that this definite pass ties up to, and compares with absolute (being non-comparative quantity) characteristic of PT signal data, and it can provide the more accurate judgement to the signal data acceptability.
In addition, because embodiments of the invention have adopted the high efficiency technical of computer mode to determine this relation, so this method and system is easy to be used by adopting or being integrated in the portable hand-held meter.In addition, the method and system according to the embodiment of the invention need not to use external perimysium reference liquid.
According to one exemplary embodiment of the present invention, a kind of method that is used for judging the acceptability of the signal data that comes from the collection of prothrombin time (PT) test-strips comprises from chemical examination zone and at least one control zone of prothrombin time test-strips gathers prothrombin time (PT) signal data.The PT test-strips that adopts in the method according to one exemplary embodiment of the present invention can be the known any suitable substance P T test-strips of those of ordinary skills, and it not only comprises the chemical examination zone but also comprises at least one control zone.Suitable PT test-strips comprises those test-strips that possess chemical examination zone, first control zone and second control zone, for example those test-strips of describing in United States Patent (USP) 6261519, United States Patent (USP) 6084660 and U.S. Patent application 10/100254 (application on March 14th, 2002) are all incorporated with these documents by reference at this.
After collecting above-mentioned PT signal data, will determine from least a relation between the PT signal data of chemically examining PT signal data that the zone collects and collecting from least one control zone.On this relation nature that is determined is comparative quantity, therefore compares with the absolute feature of PT signal data, and it is just more accurate to the judgement of PT signal data acceptability.The relation that is fit to includes but not limited to that ratio measures relation, for example from the pseudo-slope ratio (theratio of post-peak pseudo-slopes) of the postpeak of chemically examining regional and the PT signal data that at least one control zone collects, from chemically examining the peak width ratio of the PT signal data that zone and at least one control zone collection come, and be positioned at from chemically examining the area ratio of the PT signal data below that zone and at least one control zone collection come.
Then make and relevantly gather the whether acceptable judgement of the PT signal data that comes from chemically examining the zone according to above-mentioned relation.Then, for example acceptable PT signal data can be used to calculate blood coagulation collection and/or INR.This judgement for example comprises that the threshold that above-mentioned relation and at least one is predetermined makes comparisons.
Another embodiment of the present invention is a kind of PT monitoring system, and it comprises PT test-strips and a kind of device.The PT test-strips comprises chemical examination zone and at least one control zone.Described device (for example portable hand-held meter) comprises the equipment of the characteristic (for example optical reflectivity) of measuring chemical examination zone and at least one control zone.This device also comprises analog to digital converter module, microprocessor module and memory module.In this embodiment of the present invention, feature measurement equipment, analog to digital converter module, microprocessor module and memory module are fit to: (i) from chemically examining zone and at least one control zone collection PT signal data; (ii) determine from chemically examine the zone gather the PT signal data that comes with from least a relation between the next PT signal data of at least one control zone collection; And, judge from chemically examining the zone next PT signal data of collection and whether can accept (iii) according to this at least a relation.
Brief description of drawings
By being used to set forth the detailed description of the illustrative embodiment of having utilized the principle of the invention below the reference, just can understand the features and advantages of the present invention better, in the accompanying drawing:
Fig. 1 is the process flow diagram of the series of steps that adopts in the process that is illustrated in according to one exemplary embodiment of the present invention;
Fig. 2 is the simple diagram of prothrombin time test-strips, and described test-strips is used in combination with the example procedure of Fig. 1;
Fig. 3 is a curve map of describing the PT signal data, and it is included in the expander graphs according to starting point that collects in the process of the present invention and peak point zone;
Fig. 4 is the curve map from the PT signal data of chemically examining zone, first control zone and second control zone that collects in the process that is depicted in according to one exemplary embodiment of the present invention;
Fig. 5 be in the depiction 4 the PT signal data through intercepting and with curve map after corresponding smallest point is alignd;
Fig. 6 has described the curve map of the PT signal data of Fig. 5 together with the PT signal data that comes from the collection of pressure PT test-strips;
Fig. 7 is the PT signal data of depiction 5 and from the curve map of the postpeak window of chemically examining the PT signal data that gathers in the zone;
Fig. 8 is the schematic block diagram according to the PT monitoring system of one exemplary embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED
In order to allow whole instructions self-consistentency, and can be expressly understood the present invention, special wherein used term be made to give a definition:
Term " prothrombin time (PT) signal data " is meant in order to calculate the prothrombin time that is applied to the fluid sample on the PT test-strips and/or INR and the data of gathering from the PT test-strips by a kind of device.This PT signal data not only comprises original (for example observed) signal data, also comprises by hardware and/or software the original signal data are handled, conversion and/or conversion obtain consequential signal data.For example, this PT signal data for example comprises the signal amplitude data, and such as electric current, voltage or ADC readings, they are functions of time.
Fig. 1 is the series of steps of process 100 of representing to be used for to judge the acceptability of the prothrombin time signal data that comes from the collection of prothrombin time test-strips according to an one exemplary embodiment of the present invention.Just to task of explanation, will process 100 be described according to gathering the PT signal data that comes from PT test-strips 200, described test-strips 200 (as shown in Figure 2) comprises chemical examination zone 202, first control zone 204 and second control zone 206.Describe as Fig. 2, PT test-strips 200 also comprises application of sample mouth 208, passage 210, stops convergence point 212, bypass passageways 214 and bladder 216.
As illustrated in the step 110 of Fig. 1, process 100 at first comprises chemical examination zone, first control zone and second control zone collection prothrombin time (PT) signal data from PT test-strips 200.To be called A from chemically examining the zone next PT signal data of collection, will be called C1 and C2 from the PT signal data that the first and second control zone collections come.Those skilled in the art will realize that the PT test-strips that is fit to have one or more control zone according to process of the present invention.
In process 100, the PT signal data that collects has been represented to pass through to enter the light scattering of that part of whole blood sample of chemical examination zone 202, first control zone 204 and second control zone 206 of PT test-strips 200 and/or the proceeding measurement value of light absorption by passage 210.These proceeding measurement values record with predetermined time interval (being index), for example every 0.15 second.Can adopt the device such as the portable hand-held meter that has optical measuring apparatus (for example LED/ photodetector to) to come measuring light (optics) scattering and/or light absorption and collection PT signal data.But, be not limited to measuring light scattering and/or absorption according to process of the present invention.In a single day those of ordinary skills recognize that the disclosure just can recognize: this process is fit to comprise the PT signal data of the various character that characterize chemical examination zone, first and second control zone, and these character comprise electricity, magnetic, fluid and optical property.
Fig. 3 is the curve map 300 of the PT signal data that collects in the process that is depicted in according to one exemplary embodiment of the present invention, and it comprises the expander graphs in starting zone 310 and the expander graphs in peak point zone 320.Shown in expander graphs 310 and 320, the PT signal data of Fig. 3 is made of the consecutive numbers strong point of electric current to the time.
The PT signal data has four Main Stage.Starting stage (being the stage 0) is called as the pre-starting point stage, the period when it does not contain any fluid sample corresponding to the chemical examination of PT test-strips or control zone.In the stage 0, the PT signal data is a definite value, and this definite value can be used as the baseline of the other parts of comparison PT signal data.In subordinate phase (being Phase I), the range value of PT signal data descends rapidly.Should descend rapidly and be that fluid sample caused owing to the chemical examination of PT test-strips or control zone have charged into.The transition point of stage 0 to Phase I is called " starting point ".
After the full and fluid sample of chemical examination or control zone no longer flowed into the PT test-strips, the amplitude of PT signal data will raise (the Phase I that sees Fig. 3), begins descend (referring to the Phase I of Fig. 3) thereafter.The peak point of the rising among Phase and the Phase I and the generation PT signal data that descends.Prothrombin time just is defined by from starting point to the peak point elapsed time.In Fig. 3, this elapsed time is labeled as " PT time ".
Fig. 4 is the PT signal data of having described from chemical examination zone (A), first control zone (C1) and second control zone (C2) of standard (reference) PT test-strips, and they also are to collect in the process according to one exemplary embodiment of the present invention.Standard P T test-strips is the PT test-strips that also is not exposed under harmful condition, and they are with for referencial use.Fig. 5 is the curve map after the PT signal data of having described Fig. 4 aligns through intercepting and with corresponding smallest point.Intercepting, the relation between each PT signal data of more easily manifesting makes it to align with smallest point.Fig. 6 has described the curve map of the PT signal data of Fig. 5 together with the PT signal data that comes from the collection of pressure PT test-strips.The PT signal data that will come from chemical examination zone, first control zone and the second control zone collection of forcing the PT test-strips is labeled as A ', C1 ' and C2 ' respectively.
Fig. 6 is used for representing intuitively that the relation between the next PT signal data of chemical examination zone, the first and second control zone collections of forcing the PT test-strips is different from from the relation between the next PT signal time of standard (reference) PT test-strips collection.For example, the postpeak slope of A, C1 and C2 shows significantly parallel, and that the postpeak slope of A ', C1 ' and C2 ' can not manifest is obviously parallel.Be exactly to adopt this species diversity to judge the acceptability of PT signal data among the present invention.
Then illustrated according to step 120, determine first relation and second relation.First relation builds on from chemically examining the PT signal data that gathers in the zone and gather from the first area between the PT signal data that comes, second relation build on from chemically examine the zone gather the PT signal data that comes with between the next PT signal data of second control area collection.In process 100, first relation is A and the ratio of the pseudo-slope of the postpeak of C1, and second relation is A and the ratio of the pseudo-slope of postpeak of C2.But the relation of determining in according to process of the present invention is not limited to the pseudo-slope of aforesaid postpeak.In a single day those of ordinary skills have understood the disclosure, just can determine other suitable relation, and they include but not limited to the area ratio of peak width ratio and PT signal below.
For example, can utilize first and second relations of following technology deterministic process 100.At first, resolve the peak point of C1, C2 and A.These peak points are called C1 (p1), C2 (p2) and A (pa), and wherein p1, p2 and pa are respectively the peak index of C1, C2 and A.On this meaning, those of ordinary skills will appreciate that employing " index " (for example peak index) represents the point on the time shaft of C1, C2 and A.For those of ordinary skills, can utilize any known method to resolve peak point, they include but not limited to get the first order derivative of C1, C2 and A and resolve where zero passage of these first order derivatives.
Then, choose after the corresponding peak point that is positioned at each C1, C2 and a-signal () that part of signal afterwards promptly at C1 (p1), C2 (p2) and A (pa).These signals of each part are called " postpeak window ", and window width is " w ".Refer to the postpeak window of C1, C2 and A respectively with term C1W, C2W and AW.Fig. 6 is a curve map of having determined PT signal data among Fig. 4 of initial index sa (610) of the postpeak window 600 of APT signal data and APT signal data.
Generally speaking, the PT signal data in the postpeak window can be with following three The Representation Equation:
C1W＝{C1(p1+s1)，C1(p1+s1+1)，...，C1(p1+s1+w1-1)} (1)
C2W＝{C2(p2+s2)，C2(p2+s2+1)，...，C2(p2+s2+w2-1)} (2)
AW＝{A(pa+sa)，A(pa+sa+1)，...，A(pa+sa+wa-1)} (3)
Wherein
W1 is the width of C1W;
W2 is the width of C2W;
W3 is the width of AW;
S1 is the initial index of window C1W;
S2 is the initial index of window C2W;
Sa is the initial index of window AW.
Can be according to standard P T test-strips and the analysis that has been exposed to the PT test-strips under harmful condition are determined width (w1, w2 and wa) and initial index (s1, s2 and sa) in advance.The value of s1, s2 and sa can be any appropriate value, for example the value of scope in 5 to 40.In process 100, w1, w2 and wa value of being fixed as 31.What can select is that initial index s1, s2 and sa can utilize following system of equations self-adaptation to determine according to peak point and the starting point of C1, C2 and A:
Wherein, k1, k2 and k3 are the constants of being scheduled to;
T1 is start-up point (trigger point) index of C1;
T2 is the start-up point index of C2; And
Ta is the start-up point index of A.
The value of k1, k2 and k3 can be that the arbitrary value that the self-adaptation that is fit to of s1, s2 and sa is calculated can be provided.Representative value is that k1 is 0.15; K3 is 40; K2 is zero.In fact because k2 can be used for the minimum time that definite suitable window begins, therefore when k2 being set at zero, for the beginning of suitable window, there is not predetermined minimum time basically.If want, also can determine window width adaptively.But, to carry out according to process of the present invention in order to utilize limited microprocessor module, use fixedly window width is useful, can reduce required computational resource to greatest extent thus.In addition, be used for adaptively determining that the system of equations of initial index can determine according to the further feature of signal data, for example the smallest point of signal data etc.But, utilize start-up point (resembling in superincumbent equation 4,5 and 6 such) to have benefit to the noise relative insensitivity in the signal data.
Utilize above-mentioned adaptive algorithm can reduce the dependence of the pseudo-slope of postpeak to INR, this is because it can adjust the position (different with INR) of postpeak window according to the peak point of the PT signal data of being gathered.
Select postpeak window (being C1W, C2W and AW) afterwards, calculating the pseudo-slope of that part of PT signal data in each postpeak window.For example, this puppet slope can utilize the least square line that is fitted to the PT signal data in C1W, C2W and the AW to calculate in such a way:
Wherein:
I represents the index of the PT signal data in the postpeak window;
PS1 is the pseudo-slope of the postpeak of the PT signal data in the C1W;
PS2 is the pseudo-slope of the postpeak of the PT signal data in the C2W; And
PSa is the pseudo-slope of the postpeak of the PT signal data in the AW.
Equation (7) to (9) is derived from standard regression slope equation, and this equation has passed through to simplify under all PT signal datas all are assumed condition with uniform sampling rate collection and handled.Under this assumed condition, can remove the fixedly denominator in the standard regression slope equation, so that save computing time and resource.
Be used to calculate the equation of the pseudo-slope of postpeak above in a single day those of ordinary skills have understood, just will appreciate that, when w1, w2 and wa are odd number, C1W, C2W and AW " power " in the equation (7) to (9) (promptly with window width+1 and half represent) be integer, therefore can integer form carry out these calculating, can further shorten the processing time thus.In addition, also can multiply by 2 factor and obtain similar advantage by power.
Then, calculate first relation (promptly calculate A and the pseudo-slope ratio of postpeak of C1) and second relation (promptly calculate A and the postpeak puppet slope ratio of C2).The equation of these relations of expression can be write as:
Because the ratio-relation of measuring such as the pseudo-slope of above-mentioned postpeak is fiducial value in itself, thus they be relatively independent of blood group, PT test-strips batch and INR, so they are determining advantageous particularly aspect PT signal data acceptable.In case understood the disclosure, those of ordinary skills just can recognize, can also adopt other traditional mathematics, numeral or modeling technique to determine first and/or second relation, and the present invention's equation of being not limited to describe in detail above.
After having determined first and second relations, will make the judgement of the acceptability of the relevant PT signal data of gathering from the chemical examination district according to these relations according to the illustrated content of the step 130 of Fig. 1.For example, this judgement can by will utilize above-mentioned range (10) and (11) calculate pseudo-slope of postpeak and predetermined threshold (for example predetermined acceptance standard) make comparisons and finish.
What can select is that the judgement of step 130 can be carried out in such a way.At first, to a plurality of standard P T test-strips (promptly also be not exposed to the PT test-strips under harmful condition, they are also referred to as optional PT test-strips) implementation step 110 and 120.Consequently corresponding to the pseudo-slope of one group of postpeak of a plurality of standard P T test-strips.Utilize the average and covariance matrix of this class value basis of calculation PT test-strips then.Then according to following equation with all the measured value standardization in f1 and the f2 feature space:
Wherein:
f
nIt is the standardized feature space of f.
M is the mean vector of optional PT test-strips; And
∑ is the covariance matrix of optional PT test-strips.
So in this selectable process, step 130 comprises following judgement:
fn1≤k OR fb2≤k (13)
Wherein k is the error-detecting threshold value.The error-detecting threshold value can allow false positive (false positive) to select according to the maximum of a large amount of optional PT test-strips.In order to be 0.7%, utilize normal distribution that the k value is defined as 2.45 with an afterbody with false-positive percentage limit in the optional PT test-strips of standard.
Replace the dependences (being correlativity) that first and second relations can be canceled in space (top relative system of equations 12 described) by being transformed into, realized allowing first and second relations after the conversion compare thus with predetermined threshold independently.
Then, illustrated according to step 140, when the unacceptable judgement of PT signal data in step 130, made from the PT test-strips, show error messages.If desired, can whether be to judge that the unacceptable basis of PT signal data shows different error messages according to first and/or second relation.
Should be noted in the discussion above that above-mentioned equation is efficiently aspect calculating, it can be carried out in microprocessor device limited in one's ability (for example portable hand-held meter).To standard P T test-strips with force the PT test-strips (to be exposed to studies show that of hostile environment condition (promptly 38 ℃/85%R.H.) under reach 48 hours PT test-strips), process 100 (comprise above adopting equation [1] to [13]) can produce the false negative of the ratio of hanging down to forcing the PT test-strips, to standard P T test-strips and Yan Buhui produces unacceptable false positive ratio.
Fig. 8 is a simple block diagram of describing prothrombin time (PT) monitoring system 800 (dotted line is interior) according to an one exemplary embodiment of the present invention.PT monitoring system 800 comprises PT test-strips 810 and device 820.PT test-strips 810 comprises chemical examination zone and at least one control zone (all not being shown among Fig. 8).PT test-strips 810 for example comprises chemical examination zone, first control zone and second control zone.Therefore, the PT test-strips 200 of Fig. 2 can be used as the example of the PT test-strips that PT monitoring system 800 comprised.
Device 820 comprises optical measuring apparatus 822 (for example LED/ photodetector to), analog to digital converter module 823, microprocessor module 824, memory module 826 and display apparatus module 828.Module 823,824 and 826 can realize with the parts that commerce can get, or can be used as the part of ASIC (special IC).Device 820 for example can be taked the suitable form of portable hand-held meter.
Optical measuring apparatus 822 is fit to measure the optical property of chemically examining zone and at least one control zone in the PT test-strips 810.Analog to digital converter module 823 is configured to and can converts the simulation output of optical measuring apparatus 822 to digital signal.Microprocessor unit 824, memory module 826 and display apparatus module 828 can adopt the known arbitrary form of those of ordinary skills.
In PT monitoring system 800, optical measuring apparatus 822, analog to digital converter module 823, microprocessor module 824 and memory module 826 are fit to:
(i) gather the PT signal data from the chemical examination zone of PT test-strips and from least one control zone;
(ii) determine from chemically examine the zone gather the PT signal data that comes with from least a relation between at least one next PT signal data of at least one control zone collection; And
(iii) judge from chemically examining the zone next PT signal data of collection whether can accept according to this at least a relation.
In fact, device 820 will be fit to carry out the above-mentioned invention process that comprises process 100.In case understood disclosure of the present invention, those of ordinary skills just can realize optical measuring apparatus 822, analog to digital converter module 823, microprocessor module 824 and memory module 826 are carried out this improvement by utilizing traditional software, firmware and/or hardware.In addition, can make microprocessor module, memory module and display be adapted at having made from chemically examine the zone gather come the unacceptable judgement of PT signal data the time show error messages to the user.
Should be understood that, can in putting into practice process of the present invention, adopt the various alternatives of inventive embodiments described herein.Attempt to think that following claim defines scope of the present invention, it has contained the method and structure in these claim scopes and equivalent scope thereof thus.
Claims (22)
1. the method for the acceptability of the signal data that comes from the collection of prothrombin time (PT) test-strips of a judgement, this method comprises:
Gather prothrombin time (PT) signal data from the chemical examination zone of PT test-strips, and gather the PT signal data from least one control zone of PT test-strips;
Gathering definite at least a relation between PT signal data that comes and the PT signal data that comes from least one control zone collection from chemically examining the zone; And
According to this at least a relation, judge from chemically examining the zone next PT signal data of collection and whether can accept.
2. method according to claim 1, wherein this at least a relation is the ratio metric relation.
3. method according to claim 1, wherein this at least a relation is the ratio of the pseudo-slope of postpeak of the PT signal data that comes from the pseudo-slope of the postpeak of chemically examining the PT signal data that gathers in the zone with from least one control zone collection.
4. method according to claim 3, wherein the determining step utilization comprises that the technology of following content determines this at least a relation:
Peak point to the PT signal data that comes from the peak point of chemically examining the PT signal data that gathers in the zone with from least one control zone collection is resolved;
The second postpeak window of the PT signal data that selection comes from the first postpeak window of the PT signal data chemically examining the zone and gather with from least one control zone collection;
Calculate the pseudo-slope of postpeak of the first and second postpeak windows; And
Calculate the pseudo-slope of postpeak of first window and the ratio of the pseudo-slope of postpeak of second window, thereby this ratio is defined as described at least a relation.
5. method according to claim 4, wherein the pseudo-slope of the postpeak of the first and second postpeak windows can utilize the least square fitting line technology to calculate.
6. method according to claim 4, fixedly the first and second postpeak windows selected in window width and the fixing initial index of window wherein to select the step utilization.
7. method according to claim 4 wherein selects the step utilization to select the first and second postpeak windows based on the adaptive algorithm of the selection of the postpeak window on peak point.
8. method according to claim 1, wherein determination step comprises that the threshold that at least a relation and at least one is predetermined makes comparisons.
9. method according to claim 1, wherein determination step comprises the spatial alternation technology of utilizing.
10. method according to claim 1, it is further comprising the steps of:
When having made in the decision process when chemically examining the unacceptable judgement of PT signal data that the zone collects, show error messages to the user.
11. method according to claim 1, wherein
Acquisition step comprises chemical examination zone, first control zone and second control zone collection PT signal data from the PT test-strips;
Determining step comprises definite from chemically examining the next PT signal data of zone collection and concerning from first between the next PT signal data of the first control zone collection, and determine to gather second between PT signal data that comes and the PT signal data that comes from the second control zone collection and concern from chemically examining the zone, and
Determination step comprises according to first relation and the second relation judgement whether can accepting from the PT signal data of chemically examining the zone and collecting.
12. method according to claim 11, it is further comprising the steps of:
When made in the determination step from chemically examine gather in the zone the unacceptable judgement of PT signal data the time, just show error messages to the user.
13. method according to claim 12, wherein when in the determination step according to first relation made from chemically examine gather in the zone the unacceptable judgement of PT signal data the time, step display shows first error messages, when in the determination step according to second relation made from chemically examine gather in the zone the unacceptable judgement of PT signal data the time, step display shows second error messages, when in the determination step according to first and second relations made from chemically examine gather in the zone the unacceptable judgement of PT signal data the time, step display shows the 3rd error messages.
14. a method that is used for the acceptability of definite signal data from the collection of prothrombin time (PT) test-strips, this method comprises:
Gather prothrombin time (PT) signal data from the chemical examination zone of PT test-strips, gather the PT signal data, gather the PT signal data from second control zone of PT test-strips from first control zone of PT test-strips;
Determine to gather first relation between PT signal data that comes and the PT signal data that comes from the first control zone collection, and determine to gather the PT signal data that comes and concern from second between the next PT signal data of the second control zone collection from chemically examining the zone from chemically examining the zone; And
Judge from chemically examining the zone next PT signal data of collection whether can accept according to first and second relations, so that accurately judge prothrombin time.
15. method according to claim 14, wherein first relation is the ratio of the pseudo-slope of postpeak of the PT signal data that comes from the pseudo-slope of the postpeak of chemically examining the PT signal data that gathers in the zone and from the first control zone collection, and second relation is the ratio from the pseudo-slope of postpeak of the PT signal data of chemically examining the pseudo-slope of the postpeak of gathering the PT signal data that comes in the zone and coming from the second control zone collection.
16. a prothrombin time (PT) monitoring system comprises:
Comprise prothrombin time (PT) test-strips with the lower part:
The chemical examination zone; And
At least one control zone; And
Comprise device with lower member:
Optical measuring apparatus is in order to measure the optical characteristics of chemical examination zone and at least one control zone;
The analog to digital converter module;
Microprocessor module; And
Memory module,
Wherein optical measuring apparatus, analog to digital converter module, microprocessor module and memory module are fit to:
Gather prothrombin time (PT) signal data from chemically examining the zone, gather the PT signal data from least one control zone;
Determine from chemically examine the zone gather the PT signal data that comes with from least a relation between the next PT signal data of at least one control zone collection; And
Judge from chemically examining the zone next PT signal data of collection whether can accept according to this at least a relation.
17. PT monitoring system according to claim 16, wherein said device also comprises display apparatus module, wherein microprocessor module, memory module and display apparatus module be adapted at having made from chemically examine the zone gather come the unacceptable judgement of PT signal data the time show error messages to the user.
18. PT monitoring system according to claim 16, wherein the PT test-strips comprises chemical examination zone, first control zone and second control zone, and wherein optical measuring apparatus, analog to digital converter module, microprocessor module and memory module are fit to:
Gather the PT signal data from chemical examination zone, first control zone and second control zone of PT test-strips;
Determine to gather first relation between PT signal data that comes and the PT signal data that comes from the first control zone collection, and determine to gather the PT signal data that comes and concern from second between the next PT signal data of the second control zone collection from chemically examining the zone from chemically examining the zone; And
Judge from chemically examining the zone next PT signal data of collection whether can accept according to first and second relations.
19. PT monitoring system according to claim 16, wherein said device are the portable hand-held meters.
20. PT monitoring system according to claim 16, wherein said relation are that ratio is measured relation.
21. PT monitoring system according to claim 20, wherein said relation are from pseudo-slope of the postpeak of the PT signal data in chemical examination zone and ratio from the pseudo-slope of postpeak of the PT signal data of at least one control zone.
22. PT monitoring system according to claim 16, wherein optical measuring apparatus is that the LED/ photodetector is right.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/231929 | 2002-08-30 | ||
| US10/231,929 US7010432B2 (en) | 2002-08-30 | 2002-08-30 | Method and system for determining the acceptability of signal data collected from a prothrombin time test strip |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1591010A true CN1591010A (en) | 2005-03-09 |
Family
ID=31495395
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031327613A Pending CN1591010A (en) | 2002-08-30 | 2003-08-29 | Method and system for determining acceptability of signal data collected from prothrombin time test strip |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US7010432B2 (en) |
| EP (1) | EP1394546B1 (en) |
| JP (1) | JP2004132969A (en) |
| KR (1) | KR20040019996A (en) |
| CN (1) | CN1591010A (en) |
| AT (1) | ATE319999T1 (en) |
| CA (1) | CA2438924A1 (en) |
| DE (1) | DE60303889T2 (en) |
| HK (1) | HK1061275A1 (en) |
| IL (1) | IL157613A0 (en) |
| SG (1) | SG109526A1 (en) |
| TW (1) | TW200413718A (en) |
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-
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- 2003-08-27 IL IL15761303A patent/IL157613A0/en unknown
- 2003-08-28 KR KR1020030059851A patent/KR20040019996A/en not_active Application Discontinuation
- 2003-08-29 EP EP03255396A patent/EP1394546B1/en not_active Expired - Lifetime
- 2003-08-29 TW TW092123843A patent/TW200413718A/en unknown
- 2003-08-29 SG SG200304868A patent/SG109526A1/en unknown
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- 2003-08-29 JP JP2003306880A patent/JP2004132969A/en active Pending
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- 2003-08-29 AT AT03255396T patent/ATE319999T1/en not_active IP Right Cessation
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103543191A (en) * | 2012-07-16 | 2014-01-29 | 微点生物科技有限公司 | Testing of Blood Coagulation Characteristics |
| CN103543191B (en) * | 2012-07-16 | 2016-12-28 | 微点生物科技有限公司 | Inspection blood coagulation characteristic |
| CN103604766A (en) * | 2013-11-25 | 2014-02-26 | 牡丹江友搏药业股份有限公司 | Biological quality control method of Shuxuetong injection |
| CN108614017A (en) * | 2016-12-09 | 2018-10-02 | 广州好芝生物科技有限公司 | A kind of prothrombin time detection method and device |
| CN108614017B (en) * | 2016-12-09 | 2021-02-09 | 广州好芝生物科技有限公司 | Prothrombin time detection method and device |
| TWI644094B (en) * | 2017-05-05 | 2018-12-11 | 微采視像科技股份有限公司 | Method for determining prothrombin time |
| CN108956543A (en) * | 2017-05-18 | 2018-12-07 | 微采视像科技股份有限公司 | The measuring method of prothrombin time |
| CN108152517A (en) * | 2017-12-27 | 2018-06-12 | 北京乐普医疗科技有限责任公司 | A kind of device and method for testing activated partial thromboplastin time |
| CN110988321A (en) * | 2019-11-25 | 2020-04-10 | 南京岚煜生物科技有限公司 | Detection method and coagulation analysis control method of handheld coagulation analysis system |
Also Published As
| Publication number | Publication date |
|---|---|
| US20040043440A1 (en) | 2004-03-04 |
| ATE319999T1 (en) | 2006-03-15 |
| DE60303889T2 (en) | 2006-11-30 |
| EP1394546B1 (en) | 2006-03-08 |
| CA2438924A1 (en) | 2004-02-29 |
| JP2004132969A (en) | 2004-04-30 |
| DE60303889D1 (en) | 2006-05-04 |
| HK1061275A1 (en) | 2004-09-10 |
| IL157613A0 (en) | 2004-03-28 |
| KR20040019996A (en) | 2004-03-06 |
| SG109526A1 (en) | 2005-03-30 |
| TW200413718A (en) | 2004-08-01 |
| US7010432B2 (en) | 2006-03-07 |
| EP1394546A1 (en) | 2004-03-03 |
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